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PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00766324
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Nerviano Medical Sciences

Brief Summary:
To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based 1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule for further investigation.

Condition or disease Intervention/treatment Phase
Metastatic Hormone Refractory Prostate Cancer Drug: PHA-739358 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer
Study Start Date : September 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: PHA-739358
6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle
Experimental: B Drug: PHA-739358
24-hr IV infusion every 2 weeks in a 4-week cycle



Primary Outcome Measures :
  1. PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group [ Time Frame: within the first three months of treatment ]

Secondary Outcome Measures :
  1. Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit [ Time Frame: all cycles ]
  2. Overall safety profile [ Time Frame: all cycles ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic hormone refractory prostate cancer progressing after docetaxel based therapy
  • Adequate bone marrow, liver and kidney function

Exclusion Criteria:

  • More than one prior chemotherapy line
  • Uncontrolled hypertension
  • Brain or leptomeningeal disease
  • Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766324


Locations
Italy
Nerviano Medical Sciences. Clinical Research Dept.
Nerviano, Milano, Italy, 20014
Sponsors and Collaborators
Nerviano Medical Sciences

Responsible Party: Nerviano Medical Sciences
ClinicalTrials.gov Identifier: NCT00766324     History of Changes
Other Study ID Numbers: AURA-6202-007
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs